System and method for correction of a spinal disorder

ABSTRACT

A surgical system and method for fusionless correction of a spine disorder are provided. The method comprising the steps of: providing access to a spine; providing a longitudinal element extending between a first end including a first fixation element and a second end including a second fixation element; engaging the first fixation element with a first costovertebral surface and engaging the second fixation element with a second costovertebral surface such that the longitudinal element is disposed in a costotransverse orientation along a selected section of the spine; and preventing growth of the selected section of the spine with the longitudinal element.

TECHNICAL FIELD

The present disclosure generally relates to medical devices for thetreatment of musculoskeletal disorders, and more particularly to asurgical system and method for fusionless correction of a spinedisorder.

BACKGROUND

Spinal pathologies and disorders such as scoliosis and other curvatureabnormalities, kyphosis, degenerative disc disease, disc herniation,osteoporosis, spondylolisthesis, stenosis, tumor, and fracture mayresult from factors including trauma, disease and degenerativeconditions caused by injury and aging. Spinal disorders typically resultin symptoms including deformity, pain, nerve damage, and partial orcomplete loss of mobility.

Non-surgical treatments, such as medication, rehabilitation and exercisecan be effective, however, may fail to relieve the symptoms associatedwith these disorders. Surgical treatment of these spinal disordersincludes correction, fusion, fixation, discectomy, laminectomy andimplantable prosthetics. Correction treatments used for positioning andalignment may employ implants, such as vertebral rods, for stabilizationof a treated section of a spine. This disclosure describes animprovement over these prior art technologies.

SUMMARY

Accordingly, a surgical system and method for fusionless correction of aspine disorder is provided. In one embodiment, in accordance with theprinciples of the present disclosure, a method for fusionless correctionof a spine disorder is provided. The method comprising the steps of:providing access to a spine; providing a longitudinal element extendingbetween a first end including a first fixation element and a second endincluding a second fixation element; engaging the first fixation elementwith a first costovertebral surface and engaging the second fixationelement with a second costovertebral surface such that the longitudinalelement is disposed in a costotransverse orientation along a selectedsection of the spine; and preventing growth of the selected section ofthe spine with the longitudinal element.

In one embodiment, the method comprises the steps of: providing accessto a surgical site adjacent a selected section of a spine along asubstantially posterior approach; providing a tether extending between afirst end comprising a first fastener configured to penetrate bone and asecond end including a second fastener configured to penetrate bone;threading the tether in a costotransverse orientation along a pluralityof vertebral levels of the spine; engaging the first fastener topenetrate a first costovertebral surface and engaging the secondfastener to penetrate a second costovertebral surface such that thetether is disposed along the selected section of the spine; andpreventing growth of the selected section of the spine with the tether.

In one embodiment, the method comprises the steps of: providing accessto a surgical site adjacent a selected section of a spine along asubstantially posterior approach; providing a tether extending between afirst end comprising a first washer configured for non-penetratingengagement and a second end including a second washer configured fornon-penetrating engagement; threading the tether in a costotransverseorientation along a plurality of vertebral levels of the spine; engagingthe first washer with a first costovertebral surface and engaging thesecond washer with a second costovertebral surface such that the tetheris disposed along the selected section of the spine; and preventinggrowth of the selected section of the spine with the tether.

BRIEF DESCRIPTION OF THE DRAWINGS

The present disclosure will become more readily apparent from thespecific description accompanied by the following drawings, in which:

FIG. 1 is a perspective view of one particular embodiment of a systemdisposed with vertebrae in accordance with the principles of the presentdisclosure;

FIG. 2 is a perspective view of components of the system shown in FIG. 1engaging vertebrae;

FIG. 3 is a perspective view of the components and vertebrae shown inFIG. 2:

FIG. 4 is a plan view, in cross section, of the components and vertebraeshown in FIG. 2;

FIG. 5 is a plan view, in cross section, of the components and vertebraeshown in FIG. 1;

FIG. 6 is a break away perspective view of the components and vertebraeshown in FIG. 1;

FIG. 7 is a break away perspective view of the components and vertebraeshown in FIG. 1;

FIG. 8 is a perspective view of the components and vertebrae shown inFIG. 1;

FIG. 9 is a perspective view of the components and vertebrae shown inFIG. 1;

FIG. 10 a perspective view of one embodiment of a system disposed withvertebrae in accordance with the principles of the present disclosure;

FIG. 11 is a perspective view of the components and vertebrae shown inFIG. 10;

FIG. 12 is a break away perspective view of the components and vertebraeshown in FIG. 10;

FIG. 13 is a break away perspective view of the components and vertebraeshown in FIG. 10;

FIG. 14 is a perspective view of the components and vertebrae shown inFIG. 10; and

FIG. 15 is a break away perspective view of the components and vertebraeshown in FIG. 10.

Like reference numerals indicate similar parts throughout the figures.

DETAILED DESCRIPTION

The exemplary embodiments of the surgical system and related methods ofuse disclosed are discussed in terms of medical devices for thetreatment of musculoskeletal disorders and more particularly, in termsof a surgical system and method for fusionless correction of a spinedisorder. It is envisioned that the surgical system and method may beemployed in applications such as fusionless correction of deformities,such as scoliosis. For example, the surgical system and method caninclude attachment of a tether to a convex side of a spine that iscurved due to scoliosis. It is contemplated that while the tether may beaffixed to a first side of each of a plurality of vertebrae to preventgrowth of vertebrae of the first side, the system allows for growth andadjustments to a second side of the plurality of vertebrae.

In one embodiment, the system and method include placing a tether in acosto-vertebral space adjacent a posterior side of a patient. It isenvisioned that the tether can be placed on an anterior side of atransverse process. In one embodiment, the tether is engaged and/orfastened to vertebrae using screws and/or fasteners. In one embodiment,the tether is engaged and/or fastened to vertebrae using a fixationelement, such as, for example, a washer, at a transverse process/ribjunction adjacent a costovertebral space. It is contemplated that thetether may be fixed with vertebrae in two or more locations along alength of the tether.

It is envisioned that the system and method provide features along asagittal plane of a patient whereby the tether is positioned anterior toa pedicle to reduce undesired lordosis. It is further envisioned thatthe system and method provide features along a coronal plane of apatient whereby the tether is positioned in a lateral orientationrelative to a pedicle to provide more correction in the coronal plane.

In one embodiment, the components of the system are provided along asurgical pathway along a posterior approach such that the tether isdisposed in the space between a transverse process and a rib head. Thisconfiguration can avoid undesired engagement with body structures, suchas, for example, a spinal canal and vascular structures, in that thesurgical pathway is created via muscle-splitting through relativelybloodless planes. For example, the costovertebral space can include acostotransverse ligament, which can be easily penetrated bluntly. In oneembodiment, the system includes an anchor that supports a tensile loadover a transverse process and a rib head. It is contemplated that one orall of the components of the surgical system may be disposable,peel-pack, pre-packed sterile devices. One or all of the components ofthe surgical system may be reusable. The surgical system may beconfigured as a kit with multiple sized and configured components.

It is envisioned that the present disclosure may be employed to treatspinal disorders such as, for example, degenerative disc disease, discherniation, osteoporosis, spondylolisthesis, stenosis, scoliosis andother curvature abnormalities, kyphosis, tumor and fractures. It iscontemplated that the present disclosure may be employed with otherosteal and bone related applications, including those associated withdiagnostics and therapeutics. It is further contemplated that thedisclosed surgical system and methods may be alternatively employed in asurgical treatment with a patient in a prone or supine position, and/oremploy various surgical approaches to the spine, including anterior,posterior, posterior mid-line, direct lateral, postero-lateral, and/orantero-lateral approaches, and in other body regions. The presentdisclosure may also be alternatively employed with procedures fortreating the lumbar, cervical, thoracic and pelvic regions of a spinalcolumn. The system and methods of the present disclosure may also beused on animals, bone models and other non-living substrates, such as,for example, in training, testing and demonstration.

The present disclosure may be understood more readily by reference tothe following detailed description of the disclosure taken in connectionwith the accompanying drawing figures, which form a part of thisdisclosure. It is to be understood that this disclosure is not limitedto the specific devices, methods, conditions or parameters describedand/or shown herein, and that the terminology used herein is for thepurpose of describing particular embodiments by way of example only andis not intended to be limiting of the claimed disclosure. Also, as usedin the specification and including the appended claims, the singularforms “a,” “an,” and “the” include the plural, and reference to aparticular numerical value includes at least that particular value,unless the context clearly dictates otherwise. Ranges may be expressedherein as from “about” or “approximately” one particular value and/or to“about” or “approximately” another particular value. When such a rangeis expressed, another embodiment includes from the one particular valueand/or to the other particular value.

Similarly, when values are expressed as approximations, by use of theantecedent “about,” it will be understood that the particular valueforms another embodiment. It is also understood that all spatialreferences, such as, for example, horizontal, vertical, top, upper,lower, bottom, left and right, are for illustrative purposes only andcan be varied within the scope of the disclosure. For example, thereferences “upper” and “lower” are relative and used only in the contextto the other, and are not necessarily “superior” and “inferior”.

Further, as used in the specification and including the appended claims,“treating” or “treatment” of a disease or condition refers to performinga procedure that may include administering one or more drugs to apatient (human, normal or otherwise or other mammal), in an effort toalleviate signs or symptoms of the disease or condition. Alleviation canoccur prior to signs or symptoms of the disease or condition appearing,as well as after their appearance. Thus, treating or treatment includespreventing or prevention of disease or undesirable condition (e.g.,preventing the disease from occurring in a patient, who may bepredisposed to the disease but has not yet been diagnosed as having it).In addition, treating or treatment does not require complete alleviationof signs or symptoms, does not require a cure, and specifically includesprocedures that have only a marginal effect on the patient. Treatmentcan include inhibiting the disease, e.g., arresting its development, orrelieving the disease, e.g., causing regression of the disease. Forexample, treatment can include reducing acute or chronic inflammation;alleviating pain and mitigating and inducing re-growth of new ligament,bone and other tissues; as an adjunct in surgery; and/or any repairprocedure. Also, as used in the specification and including the appendedclaims, the term “tissue” includes soft tissue, ligaments, tendons,cartilage and/or bone unless specifically referred to otherwise.

The following discussion includes a description of a surgical system andrelated methods of employing the surgical system in accordance with theprinciples of the present disclosure. Alternate embodiments are alsodisclosed. Reference will now be made in detail to the exemplaryembodiments of the present disclosure, which are illustrated in theaccompanying figures. Turning now to FIGS. 1-9, there is illustratedcomponents of a surgical system, such as, for example, a fusionlesscorrection system in accordance with the principles of the presentdisclosure.

The components of the correction system can be fabricated frombiologically acceptable materials suitable for medical applications,including metals, synthetic polymers, ceramics, bone material, tissueand/or their composites, depending on the particular application and/orpreference of a medical practitioner. For example, the components of thecorrection system, individually or collectively, can be fabricated frommaterials such as stainless steel alloys, commercially pure titanium,titanium alloys, Grade 5 titanium, super-elastic titanium alloys,cobalt-chrome alloys, stainless steel alloys, superelastic metallicalloys (e.g., Nitinol, super elasto-plastic metals, such as GUM METAL®manufactured by Toyota Material Incorporated of Japan), ceramics andcomposites thereof such as calcium phosphate (e.g., SKELITE™manufactured by Biologix Inc.), thermoplastics such aspolyaryletherketone (PAEK) including polyetheretherketone (PEEK),polyetherketoneketone (PEKK) and polyetherketone (PEK), carbon-PEEKcomposites, PEEK-BaSO₄ polymeric rubbers, polyethylene terephthalate(PET), fabric, silicone, polyurethane, silicone-polyurethane copolymers,polymeric rubbers, polyolefin rubbers, hydrogels, semi-rigid and rigidmaterials, elastomers, rubbers, thermoplastic elastomers, thermosetelastomers, elastomeric composites, rigid polymers includingpolyphenylene, polyamide, polyimide, polyetherimide, polyethylene,epoxy, bone material including autograft, allograft, xenograft ortransgenic cortical and/or corticocancellous bone, and tissue growth ordifferentiation factors, partially resorbable materials, such as, forexample, composites of metals and calcium-based ceramics, composites ofPEEK and calcium based ceramics, composites of PEEK with resorbablepolymers, totally resorbable materials, such as, for example, calciumbased ceramics such as calcium phosphate, tri-calcium phosphate (TCP),hydroxyapatite (HA)-TCP, calcium sulfate, or other resorbable polymerssuch as polyaetide, polyglycolide, polytyrosine carbonate,polycaroplaetohe and their combinations. Various components of thesystem may have material composites, including the above materials, toachieve various desired characteristics such as strength, rigidity,elasticity, compliance, biomechanical performance, durability andradiolucency or imaging preference. The components of the system,individually or collectively, may also be fabricated from aheterogeneous material such as a combination of two or more of theabove-described materials. The components of the system may bemonolithically formed, integrally connected or include fasteningelements and/or instruments, as described herein.

The system is employed, for example, with an open, mini-open orminimally invasive surgical technique to attach a longitudinal elementto a first side, such as, for example, a convex side of a spine that hasa spinal disorder. In one embodiment, the longitudinal element may beaffixed to the convex side of each of a plurality of vertebrae such thatthe system prevents growth of vertebrae of a selected section of thespine while allowing for growth and adjustments to a second side, suchas, for example, a concave side of the plurality of vertebrae for acorrection treatment to treat various spine pathologies, such as, forexample, adolescent idiopathic scoliosis and Scheuermann's kyphosis.

The present system includes a longitudinal element, such as, forexample, a tether 20 that extends between a first end 22 and a secondend 24. Tether 20 has a flexible configuration, which includes movementin a lateral or side to side direction and prevents expanding and/orextension in an axial direction upon fixation with vertebrae, as will bedescribed. It is envisioned that all or only a portion of tether 20 mayhave a semi-rigid, rigid or elastic configuration, and/or have elasticproperties such that tether 20 provides a selective amount of expansionand/or extension in an axial direction. It is further envisioned thattether 20 may be compressible in an axial direction. Tether 20 caninclude a plurality of separately attachable or connectable portions orsections, such as bands or loops, or may be monolithically formed as asingle continuous element.

Tether 20 has an outer surface 26 and a uniform thickness/diameter. Itis envisioned that outer surface 26 may have various surfaceconfigurations, such as, for example, rough, threaded for connectionwith surgical instruments, arcuate, undulating, porous, semi-porous,dimpled, polished and/or textured according to the requirements of aparticular application. It is contemplated that the thickness defined bytether 20 may be uniformly increasing or decreasing, or have alternatediameter dimensions along its length. It is further contemplated thattether 20 may have various cross section configurations, such as, forexample, oval, oblong, triangular, rectangular, square, polygonal,irregular, uniform, non-uniform, variable and/or tapered.

It is contemplated that tether 20 may have various lengths, according tothe requirements of a particular application. It is further contemplatedthat tether 20 may be braided, such as a rope, or include a pluralityelongated elements to provide a predetermined force resistance. It isenvisioned that tether 20 may be made from autograft and/or allograft,as described above, and be configured for resorbable or degradableapplications.

It is contemplated that the longitudinal element may include one or aplurality of flexible wires, staples, cables, ribbons, artificial and/orsynthetic strands, rods, plates, springs, and combinations thereof. Inone embodiment, the longitudinal element is a cadaver tendon. In oneembodiment, the longitudinal element is a solid core. In one embodiment,the longitudinal element is tubular.

The system includes a first fixation element, such as, for example, abone screw 30 connected with first end 22 and a second fixation element,such as, for example, a bone screw 40 connected with second end 24.Screws 30, 40 may be monolithically formed, integrally connected orattached with fastening elements to tether 20. The system includes aplurality of third fixation elements, such as, for example, bone screws32 disposed intermediate first end 22 and second end 24, and connectedto tether 20 between screws 30, 40 along the length of tether 20. Screws32 may be monolithically formed, integrally connected or attached withfastening elements to tether 20. It is envisioned that one or aplurality of screws 32 may be connected with tether 20. It is furtherenvisioned that the system may not include screw(s) 32.

Screws 30, 40, 32 are configured for penetrating fixation with tissue ofvertebrae along a plurality of vertebral levels. Each of screws 30, 40,32 are disposed to engage a separate vertebral level. It is contemplatedone or a plurality of fixation elements may be employed with a singlevertebral level. It is further contemplated that the fixation elementsmay be engaged with vertebrae in various orientations, such as, forexample, series, parallel, offset, staggered and/or alternate vertebrallevels. It is envisioned that the fixation elements may include one or aplurality of anchors, tissue penetrating screws, conventional screws,expanding screws, wedges, anchors, buttons, clips, snaps, frictionfittings, compressive fittings, expanding rivets, staples, nails,adhesives, posts, fixation plates and/or posts. These fixation elementsmay be coated with an osteoinductive or osteoconductive material toenhance fixation, and/or include one or a plurality of therapeuticagents.

In assembly, operation and use, a fusionless correction system, similarto the system described above, is employed with a surgical procedure,such as, for a correction treatment to treat adolescent idiopathicscoliosis and/or Scheuermann's kyphosis of a spine. It is contemplatedthat one or all of the components of the fusionless correction systemcan be delivered or implanted as a pre-assembled device or can beassembled in situ. The fusionless correction system may be completely orpartially revised, removed or replaced.

For example, as shown in FIGS. 1-9, the fusionless correction system canbe employed with a surgical correction treatment of an applicablecondition or injury of an affected section of a spinal column andadjacent areas within a body, such as, for example, a first vertebra V1,a second vertebra V2 and a plurality of vertebra disposed therebetween,such as, for example, third vertebrae V3, of vertebrae V.

In use, to treat a selected section S of vertebrae V, a medicalpractitioner obtains access to a surgical site including vertebrae V inany appropriate manner, such as through incision and retraction oftissues. It is envisioned that the fusionless correction system can beused in any existing surgical method or technique including opensurgery, mini-open surgery, minimally invasive surgery and percutaneoussurgical implantation, whereby vertebrae V is accessed through amini-incision, or sleeve that provides a protected passageway to thearea. Once access to the surgical site is obtained, the particularsurgical procedure can be performed for treating the spine disorder. Theconfiguration and dimension of tether 20 is determined according to theconfiguration and dimension of selected section S and the requirementsof a particular application.

An incision is made in the body of a patient and a cutting instrument(not shown) creates a surgical pathway along a substantially posteriorapproach, as shown by arrow A in FIG. 4, for implantation of componentsof the fusionless correction system within the patient body. A sleeve orcannula is used to access a costovertebral space CS1, as shown in FIG.5, adjacent vertebra V1 and facilitate delivery and access forcomponents of the fusionless correction system along the surgicalpathway, for example, such that tether 20 is disposed in acostovertebral space CS1 between costovertebral surfaces, which includesurfaces of a transverse process TP1, a rib head RH1 and vertebra V1. Itis contemplated that this method and configuration avoid undesiredengagement with body structures, such as, for example, a spinal canaland vascular structures, in that the surgical pathway is created viamuscle-splitting through relatively bloodless planes. A preparationinstrument (not shown) can be employed to prepare tissue surfaces ofvertebrae V and adjacent nrib surfaces, as well as for aspiration andirrigation of the region according to the requirements of a particularsurgical application.

Screw 30 is configured to support a tensile load with tether 20 overcostovertebral surfaces, which include surfaces of transverse processTP1 and rib head RH1. A pilot hole is made in vertebra V1 for receivingscrew 30. Screw 30 is delivered along the surgical pathway adjacentcostovertebral space CS1 for penetrating engagement with vertebra V1.Screw 30 includes a threaded bone engaging portion 34 that is insertedor otherwise engaged with vertebra V1, according to the particularrequirements of the surgical treatment. Screw 30 has a head 36 with abore, or through opening and a set screw 38, which is torqued on totether 20, as will be described.

One or a plurality of screws 32 are configured to support a tensile loadwith tether 20 over one or a plurality of costovertebral surfaces, whichinclude surfaces of transverse processes TP3, rib heads RH3 and vertebraV3. A pilot hole is made in vertebra V3 for receiving screw 32. Screw 32is delivered along the surgical pathway, or an alternate surgicalpathway along a substantially posterior approach, adjacent acostovertebral space CS3 for penetrating engagement with vertebra V3.Screw 32 includes a threaded bone engaging portion 33 that is insertedor otherwise engaged with vertebra V3, according to the particularrequirements of the surgical treatment. Screw 32 has a head 37 with abore, or through opening and a set screw 44, which is torqued on totether 20.

Screw 40 is configured to support a tensile load with tether 20 overcostovertebral surfaces, which include surfaces of a transverse processTP2, a rib head RH2 and vertebra V2. A pilot hole is made in vertebra V2for receiving screw 40. Screw 40 is delivered along the surgicalpathway, or an alternate surgical pathway along a substantiallyposterior approach, adjacent a costovertebral space CS2 for penetratingengagement with vertebra V2. Screw 40 includes a threaded bone engagingportion 46 that is inserted or otherwise engaged with vertebra V2,according to the particular requirements of the surgical treatment.Screw 40 has a head 48 with a bore, or through opening and a set screw60, which is torqued on to tether 20.

Tether 20 is delivered along the surgical pathway to costovertebralspace CS1 for attachment with screw 30. Set screw 38 of head 36 istorqued on to the portion of tether 20 disposed with screw 30 tosecurely fix first end 22 of tether 20 with vertebra V1. Tether 20 isdisposed in costovertebral space CS1 on a posterior side of vertebra Vsuch that tether 20 is disposed on an anterior side of transverseprocess TP1.

Tether 20 is threaded in a costotransverse orientation along vertebra Vand one or a plurality of vertebra V3. Set screw 44 of head 37 istorqued on to an intermediate portion 52 of tether to attach to screw 32to securely fix intermediate portion 52 with vertebra V3. Tether 20 isdisposed in costovertebral space CS3 on a posterior side of vertebra V3such that tether 20 is disposed on an anterior side of transverseprocess TP3.

Tether 20 is threaded in a costotransverse orientation along vertebra V3and vertebra V2. Set screw 60 of head 48 is torqued on to the portion oftether 20 disposed with screw 40 to securely fix second end 24 withvertebra V2. Tether 20 is disposed in costovertebral space CS2 on aposterior side of vertebra V2 such that tether 20 is disposed on ananterior side of transverse process TP2.

As shown in FIGS. 1, 8 and 9, the components of the fusionlesscorrection system are attached with a first side, such as, for example,a convex side CX of vertebrae V to prevent growth of selected section S,while allowing for growth and adjustments to a second side, such as, forexample, a concave side CV of vertebrae V to provide treatment.Compression of section S of vertebrae V occurs along convex side CX, asshown by arrows B in FIG. 9. It is envisioned that this method andconfiguration implant components of the fusionless correction systemalong a sagittal plane of a patient such that tether 20 is disposedanterior to a pedicle to reduce undesired lordosis. It is furtherenvisioned that this method and configuration implant components of thefusionless correction system along a coronal plane of a patient wherebytether 20 is disposed in a lateral orientation relative to a pedicle toprovide correction in the coronal plane.

In one embodiment, the fusionless correction system includes an agent,which may be disposed, packed or layered within, on or about thecomponents and/or surfaces of the fusionless correction system. It isenvisioned that the agent may include bone growth promoting material,such as, for example, bone graft to enhance fixation of the fixationelements with vertebrae V.

It is contemplated that the agent may include therapeuticpolynucleotides or polypeptides. It is further contemplated that theagent may include biocompatible materials, such as, for example,biocompatible metals and/or rigid polymers, such as, titanium elements,metal powders of titanium or titanium compositions, sterile bonematerials, such as allograft or xenograft materials, synthetic bonematerials such as coral and calcium compositions, such as HA, calciumphosphate and calcium sulfite, biologically active agents, for example,gradual release compositions such as by blending in a bioresorbablepolymer that releases the biologically active agent or agents in anappropriate time dependent fashion as the polymer degrades within thepatient. Suitable biologically active agents include, for example, BMP,Growth and Differentiation Factors proteins (GDF) and cytokines. Thecomponents of the fusionless correction system can be made ofradiolucent materials such as polymers. Radiomarkers may be included foridentification under x-ray, fluoroscopy, CT or other imaging techniques.It is envisioned that the agent may include one or a plurality oftherapeutic agents and/or pharmacological agents for release, includingsustained release, to treat, for example, pain, inflammation anddegeneration.

It is envisioned that the use of microsurgical and image guidedtechnologies may be employed to access, view and repair spinaldeterioration or damage, with the aid of the fusionless correctionsystem. Upon completion of the procedure, the surgical instruments andassemblies are removed and the incision is closed.

In one embodiment, as shown in FIGS. 10-15, the fusionless correctionsystem, similar to the components and method described with regard toFIGS. 1-9, includes a longitudinal element, such as, for example, atether 120, similar to tether 20 described above, which extends betweena first end 122 and a second end 124.

A first fixation element, such as, for example, a washer 130 isconnected with first end 122 and a second fixation element, such as, forexample, a washer 140 is connected with second end 124. Washers 130, 140may be monolithically formed, integrally connected or attached withfastening elements to tether 120. In one embodiment, the system mayinclude a plurality of third fixation elements, such as, for example,washers disposed intermediate first end 122 and second end 124, andconnected to tether 120 between washers 130, 140 along the length oftether 120.

Washers 130, 140 are configured for non-penetrating engagement with acostovertebral surface of a vertebra along a plurality of vertebrallevels. Each of washers 130, 140 are disposed to engage a separatevertebral level. Washer 130 defines a planar surface 132 configured toengage a costovertebral surface of a vertebrae to facilitate fixation offirst end 122 with the costovertebral surface. Washer 140 defines aplanar surface 142 configured to engage a costovertebral surface of avertebrae to facilitate fixation of second end 124 with thecostovertebral surface. It is contemplated one or a plurality of washersmay be employed with a single vertebral level. It is furthercontemplated that the fixation elements may be engaged with vertebrae invarious orientations, such as, for example, series, parallel, offset,staggered and/or alternate vertebral levels. The washers may be coatedwith an osteoinductive or osteoconductive material to enhance fixation,and/or include one or a plurality of therapeutic agents. It isenvisioned that ends 122, 124 may include a stop to facilitate fixationwith washers 130, 140, which may include knots, endcaps, locks, clips orpins.

For example, as shown in FIGS. 10-15, the fusionless correction systemincluding washers 130, 140 can be employed with a surgical correctiontreatment, similar to that described above, of an applicable conditionor injury of an affected section of a spinal column and adjacent areaswithin a body, such as, for example, a first vertebra V1′, a secondvertebra V2′ and a plurality of vertebra disposed therebetween, such as,for example, third vertebrae V3′, of vertebrae V′.

An incision is made in the body of a patient and a cutting instrument(not shown) creates a surgical pathway along a substantially posteriorapproach for implantation of components of the fusionless correctionsystem within the patient body. A sleeve or cannula is used to access acostovertebral space CS1′ adjacent vertebra V1′ and facilitate deliveryand access for components of the fusionless correction system along thesurgical pathway, for example, such that tether 120 is disposed in acostovertebral space CS1′ between costovertebral surfaces, which includesurfaces of a transverse process TP1′, a rib head RH1′ and vertebra V1′.

Washer 130 is configured to support a tensile load with tether 120 overcostovertebral surfaces, which include surfaces of transverse processTP1′ and rib head RH1′. With tether 120 attached to washer 130 adjacentfirst end 122, washer 130 is delivered along the surgical pathwayadjacent costovertebral space CS1′ for non-penetrating engagement withvertebra V1′. In one embodiment, tether 120 is delivered along thesurgical pathway to costovertebral space CS1′ for attachment with washer130.

First end 122 of tether 120 is securely fixed to washer 130. Planarsurface 132 engages the costovertebral surface of vertebra V′ such thatwasher 130 is fixed in a non-penetrating engagement with vertebra V1′.Tether 120 is disposed in costovertebral space CS1′ on a posterior sideof vertebra V1′ such that tether 120 is disposed on an anterior side oftransverse process TP1′. Tether 120 is threaded in a costotransverseorientation along vertebra V1′ along one or a plurality of vertebrallevels.

Second end 124 of tether 120 is securely fixed to washer 140. Planarsurface 142 engages the costovertebral surface of vertebra V2′ such thatwasher 140 is fixed in a non-penetrating engagement with vertebra V2′.Tether 120 is disposed in costovertebral space CS2′ on a posterior sideof vertebra V2′ such that tether 120 is disposed on an anterior side oftransverse process TP2′. In one embodiment, a plurality of washers maybe utilized, disposed intermediate ends 122, 124 and vertebrae V1′, V2′,along a plurality of vertebral levels of vertebrae V.

The components of the fusionless correction system including washers130, 140 are attached with a first side, such as, for example, a convexside CX′ of vertebrae V′ to prevent growth of selected section S′, whileallowing for growth and adjustments to a second side, such as, forexample, a concave side CV′ of vertebrae V′ to provide treatment.Compression of section S′ of vertebrae V′ occurs along convex side CX′,as shown by arrows B′ in FIG. 15.

It is contemplated that the components of the fusionless correctionsystem and method of use for fusionless tethering of deformities may beemployed to treat progressive idiopathic scoliosis with or withoutsagittal deformity in either infantile or juvenile patients, includingbut not limited to prepubescent children, adolescents from 10-12 yearsold with continued growth potential, and/or older children whose growthspurt is late or who otherwise retain growth potential. It is furthercontemplated that the components of the fusionless correction system andmethod of use may be used to prevent or minimize curve progression inindividuals of various ages.

It will be understood that various modifications may be made to theembodiments disclosed herein. Therefore, the above description shouldnot be construed as limiting, but merely as exemplification of thevarious embodiments. Those skilled in the art will envision othermodifications within the scope and spirit of the claims appended hereto.

What is claimed is:
 1. A method for fusionless correction of a spinedisorder, the method comprising the steps of: providing access to aspine; providing a longitudinal element extending between a first endincluding a first fixation element and a second end including a secondfixation element, wherein at least one of the first fixation element andthe second fixation element is a bone screw comprising a threaded boneengaging portion; engaging the first fixation element with a firstcostovertebral surface and engaging the second fixation element with asecond costovertebral surface such that the longitudinal element isdisposed in a costotransverse orientation along a selected section ofthe spine; and preventing growth of the selected section of the spinewith the longitudinal element.
 2. A method as recited in claim 1,wherein the step of providing access includes creating a pathway to asurgical site adjacent the selected section of the spine via asubstantially posterior approach.
 3. A method as recited in claim 1,wherein the step of providing access includes a minimally invasivetechnique for creating a pathway to the spine.
 4. A method as recited inclaim 1, wherein the longitudinal element includes a tether.
 5. A methodas recited in claim 1, wherein the longitudinal element includes acadaver tendon.
 6. A method as recited in claim 1, wherein thelongitudinal element includes a solid core.
 7. A method as recited inclaim 1, wherein the longitudinal element is tubular.
 8. A method asrecited in claim 1, wherein the first fixation element is configured topenetrate bone.
 9. A method as recited in claim 1, wherein the step ofengaging includes threading the longitudinal element in thecostotransverse orientation through a plurality of costovertebral spacesdisposed along a plurality of vertebral levels.
 10. A method as recitedin claim 1, wherein the step of engaging the first fixation element withthe first costovertebral surface includes penetrating bone.
 11. A methodas recited in claim 1, wherein the step of engaging the first fixationelement with the first costovertebral surface includes penetrating bonefrom a posterior approach.
 12. A method as recited in claim 1, whereinthe step of engaging the first fixation element with the firstcostovertebral surface includes a non-penetrating engagement.
 13. Amethod as recited in claim 1, wherein the first fixation elementincludes a planar surface and the step of engaging the first fixationelement with the first costovertebral surface includes engaging theplanar surface with the first costovertebral surface.
 14. A method asrecited in claim 1, wherein the first costovertebral surface is spacedapart from the second costovertebral surface over a plurality ofvertebral levels.
 15. A method as recited in claim 1, wherein thelongitudinal element includes a third fixation element disposedintermediate the first end and the second end and further comprising thestep of engaging the third fixation element with a third costovertebralsurface disposed intermediate the first costovertebral surface and thesecond costovertebral surface.
 16. A method as recited in claim 1,wherein the threaded bone engaging portion is connected to a head havinga cavity configured for disposal of the longitudinal element, an innersurface of the head comprising threads configured to engage threads of abone fastener to fix the longitudinal element relative to the head. 17.A method for fusionless correction of a spine disorder, the methodcomprising the steps of: providing access to a surgical site adjacent aselected section of a spine along a substantially posterior approach;providing a tether extending between a first end comprising a firstfastener configured to penetrate bone and a second end including asecond fastener configured to penetrate bone; threading the tether in acostotransverse orientation along a plurality of vertebral levels of thespine; engaging the first fastener to penetrate a first costovertebralsurface and engaging the second fastener to penetrate a secondcostovertebral surface such that the tether is disposed along theselected section of the spine; and preventing growth of the selectedsection of the spine with the tether.
 18. A method as recited in claim17, wherein the tether includes a plurality of fasteners configured topenetrate bone and being disposed intermediate the first end and thesecond end, and further comprising the step of engaging the plurality offasteners to penetrate a plurality costovertebral surfaces disposedintermediate the first costovertebral surface and the secondcostovertebral surface.
 19. A method for fusionless correction of aspine disorder, the method comprising the steps of: providing access toa surgical site adjacent a selected section of a spine along asubstantially posterior approach; providing a tether extending between afirst end comprising a first washer configured for non-penetratingengagement and a second end including a second washer configured fornon-penetrating engagement; threading the tether in a costotransverseorientation along a plurality of vertebral levels of the spine; engagingthe first washer with a first costovertebral surface and engaging thesecond washer with a second costovertebral surface such that the tetheris disposed along the selected section of the spine; and preventinggrowth of the selected section of the spine with the tether.
 20. Amethod as recited in claim 19, wherein the tether includes a pluralityof washers configured for non-penetrating engagement and being disposedintermediate the first end and the second end, and further comprisingthe step of engaging the plurality of washers with a pluralitycostovertebral surfaces disposed intermediate the first costovertebralsurface and the second costovertebral surface.